REJUVENIQUE MODEL #RJV10

K011935 · Salton, Inc. · NFO · Aug 8, 2001 · Neurology

Device Facts

• Record ID: K011935
• Device Name: REJUVENIQUE MODEL #RJV10
• Applicant: Salton, Inc.
• Product Code: NFO · Neurology
• Decision Date: Aug 8, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rejuvenique System is indicated for cosmetic use.

Device Story

Rejuvenique facial toning system; consists of PVC face mask, connecting cable, and control unit. Mask features 26 fixed-position, gold-plated brass electrodes; held by adjustable headband. Control unit powered by 9V battery; contains microprocessor. Device delivers pulsed biphasic electrical stimulation to facial muscles. Operation: microprocessor cycles stimulation through 12 electrode pairs sequentially; 20 seconds per pair; full cycle ~4 minutes; total session ~20 minutes before automatic shut-off. User-operated; intended for home use. Facial point location display indicates active electrode pair. Output intensity adjustable via uncalibrated knob. Benefits: cosmetic facial toning via neuromuscular stimulation.

Clinical Evidence

Clinical efficacy and safety data were submitted in the application. No specific study metrics, sample sizes, or statistical results provided in the summary document.

Technological Characteristics

Materials: ABS plastic housing, PVC mask, gold-plated brass electrodes. Energy: 9V battery. Waveform: Pulsed biphasic (rectangular positive phase, exponential negative phase). Pulse width: 300 microseconds. Frequency: 8 Hz. Output: Regulated voltage, 1 channel, alternating to 12 electrode groups. Connectivity: None. Software: Microprocessor-controlled sequencing and automatic shut-off.

Indications for Use

Indicated for cosmetic use. No specific patient population, age, or disease state defined.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• TENS devices

Submission Summary (Full Text)

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K011935

# AUG = 8 2001

# 510(k) SUMMARY REJUVENIQUE® FACIAL TONING SYSTEM

#### Applicant/Address

- Salton, Inc., 1955 W. Field Court, Lake Forest, IL 60045 ם
#### Contact Person/Telephone

- Leon Dreimann, Chief Executive Officer, (PH) 847-803-4600 ext. 1200; (FAX) 847-803-1211
### Preparation Date

- 2001 August 7, 2001
#### Device Trade Name

- Rejuvenique® o
#### Classification Name

- TENS Device(21 CFR 882.5890)
#### Legally Marketed Predicate Devices

- a TENS devices.
#### Device Description

- The Rejuvenique facial toning system consists of three connected components a face ם mask, connecting cable and control unit. The mask is a PBC mask that is shaped to fit over the user's face. It is held on the user's face by an adjustable headband. It contains 26 fixed-position, gold plated, brass electrodes. The connecting cable is an 8-conducter cable in a PVC jacket. It connects the face mask to the control unit by modular, phone jack-style plugs on each end. The Control Unit contains the power-source ( a nine-volt battery), and the microprocessor control.
- When the Rejuvenique® system is activated, it provides a stimulus to the first pair of electrodes for 20 seconds, and then the microprocessor automatically switches to the next pair of electrodes in the sequence. The Facial Point Location Display indicates which pair of electrodes are currently activated (1-12). A full cycle through the 12 pairs of electrodes requires approximately 4 minutes. Unless stopped by the user the product will go through four complete cycles (approximately 20 minutes), and then automatically shuts off.

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## Intended Use

- ロ Rejuvenique® is indicated for cosmetic use.
### Substantial Equivalence Summary

- O Rejuvenique® is substantially equivalent to legally marketed TENS devices.
# Technological Characteristics

### Basic Unit Characteristics

| | 1. Power Source(s): | Single 9V Battery |
|------------------------|-------------------------------------------|--------------------------------------|
| | 2. Number of Output Modes: | 1 |
| 3. | Number of Output Channels: | 1 channel |
| | - Synchronous or Alternating? | Alternating into 12 electrode groups |
| | - Method of Channel Isolation | Electrode group selected by relays |
| | 4. Regulated Current or Voltage? | Regulated Voltage |
| 5. | Software/Firmware/Microprocessor Control? | Yes |
| | 6. Automatic Overload Trip? | No |
| 7. | Automatic No-Load Trip? | No |
| | 8. Automatic Shut Off? | Yes |
| 9. | Patient Override Control? | Yes |
| 10. Indicator Display: | | |
| | - On/Off Status? | Yes |
| | - Low Battery? | Yes |
| | - Voltage/Current Level? | Yes, Uncalibrated Knob |
| | 11. Timer Range (minutes) | Fixed 16 minutes |
| | 12. Compliance with 21 CFR 898 | Yes |
| | 13. Weight | 80 grams |
| | 15. Dimensions (in.) [WxHxD] | 4-1/2" x 3" x 1-1/4 |
| | 16. Housing Materials and Construction | ABS Plastic, snap latch assembly |

### Output Specifications

| 1. Waveform: | Pulsed Biphasic |
|----------------------------|----------------------------------------|
| 2. Shape: | Rectangular (+ phase), Spike (- phase) |
| 3. Maximum Output Voltage: | 18.8V @ 500 Ohms |
| 4. (+/- 10 %) | 24.8V @ 2k Ohms |
| 5. | 28.0V @ 10k Ohms |
| 6. Maximum Output Current: | 37.6mA @ 500 Ohms |
| 7. (+/- 10 %) | 12.4mA @ 2k Ohms |
| 8. | 2.8mA @ 10k Ohms |
| 9. Pulse Width | 300 microseconds fixed |
| 10. Frequency (Hz) | 8 Hz fixed |
| 11. Beat Frequency (Hz) | N/A |
| 12. Symmetrical Phases | No |

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- 13. Phase Duration: (both phases, if asymmetrical)
- Net Charge (microC per pulse) 14. (if zero, state method to achieve)
- ાં રેં. Maximum Phase Charge, (microC)
- Maximum Current Density 16.

300 microseconds (+ phase) 124.7 milliseconds (- phase, exponential) 0 @ 500 Ohms Transformer Coupling 11.3 microCoulombs @ 500 Ohms 46.4 mA/cm2 @ 500 Ohms

Sample Calculation:

Jmax = Imax/(pi * D2/4) = 37.6 mA/(3.1416 * (1.016 cm)^2 / 4) = 46.4 mA/cm2 Assumes only one electrode pair contacting. If both pairs make contact, Jmax is 23.2 mA/cm-

Maximum Power Density, (W/cm2) 17.

2.31 mW/cm2

Sample Calculation:

Pmax = Jmax * Vmax * 0.3 ms/125 ms + V- * J- * 2.8 ms/125 ms Pmax = 46.4 mA/cm2 * 18.8 * 0.0024 + 2.0V * 4.93 mA/cm2 * 0.0224 Pmax = 2.093 mW/cm2 + 0.221 mW/cm2 = 2.31 mW/cm2 First portion is positive phase, second is negative phase. Assumes negative Phase is square shaped with constant amplitude equal to initial negative spike. This slightly overestimates the power density of the negative phase.

- Burst Mode: 18. 160 pulses a. Pulses per burst 1/240 (per electrode group) b. Bursts per second c. Burst duration 20 seconds d. Duty Cycle 1/12
On Time (Seconds) 19.

20 seconds/electrode group

Testing

- Clinical efficacy and safety data was submitted in the application.
### Conclusion

- o Based on the foregoing, Salton believes the Rejuvenique® facial toning system is substantially equivalent to legally marketed predicate TENS devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Georgia C. Ravitz Counsel for Salton, Inc. Arent Fox Kinter Plotkin & Kahn, PLLC 1050 Connecticut Avenue, NW Washington, DC 20036-5339

Re: 510(k) Number K011935 Trade/Device Name: Rejuvenique® System, Model RJV-10 Regulation Numbers: 21 CFR 882.5890 and 21 CFR 882.1275 Regulatory Class: II Product Codes: NFO and GYB Dated: June 20, 2001 Received: June 21, 2001

Dear Ms. Ravitz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

AUG - 8 2001

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Georgia C. Ravitz

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2T CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

David C. Schultz, M.D.

Daniel G. Schultz, M.D. Deputy Director for Clinical and Review Policy Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__1 __of__1

510(k) Number (if known): ___K011935

Device Name: Rejuvenique® System, Model RJV-10

Indications For Use:

The Rejuvenique System is indicated for cosmetic use.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Mullens

Collig35

Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number _